Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of pancreatic cancer.

PURPOSE: This phase II trial is studying the side effects and how well vaccine therapy works in treating patients with pancreatic cancer that has been removed by surgery.

Further Study Information

OBJECTIVES:

Primary

• Determine the safety of primary and boost vaccinations with lethally irradiated allogeneic pancreatic tumor cells transfected with sargramostim (GM-CSF) gene vaccine in patients with surgically resected adenocarcinoma of the head, neck, or uncinate of the pancreas.

Secondary

• Correlate specific in vivo parameters of immune response (e.g., mesothelin, prostate stem cell antigen, and mutated k-ras-specific T-cell responses) with clinical response in patients treated with this regimen.

• Determine the efficacy, in terms of overall and recurrence-free survival, of this regimen in these patients.

• Correlate serum GM-CSF levels with longevity of an allogeneic vaccine after semi-annual boosting in these patients.

• Determine the psychosocial (e.g., demographics, quality of life, hope, trust, social support, decision control, and advanced directives) and symptom (e.g., pain, anorexia, fatigue, and mood state) profiles in these patients and explore changes over time.

OUTLINE: This is a open-label study. Patients are stratified according to prior vaccination with allogeneic sargramostim (GM-CSF)-secreting pancreatic tumor cell vaccine (yes [stratum I] vs no [stratum II]).

• Stratum I: Patients receive booster vaccination comprising allogeneic GM-CSF plasmid DNA pancreatic tumor cell vaccine subcutaneously (SC). Treatment repeats every 6 months in the absence of disease progression or unacceptable toxicity.

• Stratum II: Patients receive priming vaccinations SC once a month for 3 months and then receive booster vaccinations as in stratum I.

Patients complete self-reported psychosocial (including quality of life, hope, and trust) and symptom (including pain, fatigue, anorexia, and mood) questionnaires at day 0 and day 28.

After completion of study treatment, patients are followed at day 28 and then annually for 15 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of adenocarcinoma of the head, neck, tail, or uncinate of the pancreas meeting the following criteria:

• Stage I-III disease

• Prior surgical resection required

• No radiographic evidence of disease recurrence

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Hemoglobin ≥ 9 g/dL

• Absolute neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 2.0 mg/dL

• Bilirubin ≤ 2.0 mg/dL (unless due to known Gilbert's syndrome)

• AST, ALT, and amylase ≤ 2 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other uncontrolled illness

• No active, ongoing infection

• No history of autoimmune disease (e.g., systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 28 days since prior anticancer therapy (e.g., adjuvant chemoradiotherapy)

• At least 28 days since prior systemic steroid therapy

• At least 6 months since last vaccination with sargramostim (GM-CSF) plasmid DNA pancreatic tumor cell vaccine (cell lines Panc 10.05 and Panc 6.03) while enrolled on SKCCC-J9617 or SKCCC-J9988

• No concurrent systemic steroid therapy during and for ≥ 28 days after vaccination

• No concurrent radiation therapy

• No other concurrent immunotherapy, biologic therapy, or gene therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Daniel A. Laheru

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00389610
Information obtained from ClinicalTrials.gov on December 14, 2011

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